Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Understanding How Cognitive Remediation Works (Cog-2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Boston University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Boston University
ClinicalTrials.gov Identifier:
NCT01683539
First received: August 17, 2012
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

This study is aimed at evaluating whether the computer-based cognitive exercises in the Thinking Skills for Work (TSW) program are critical to improving work and cognitive outcomes in consumers with serious mental illness and cognitive impairment enrolled in supported employment (SE), or whether a streamlined version of TSW without this component (the Cognitive Skills for Work (CSW) program) is equally effective for some or all consumers. An RCT will be conducted at two sites (Mental Health Center of Greater Manchester in New Hampshire and Thresholds Inc. in Illinois) with 244 consumers randomly assigned to one of two groups (122 each, with approximately 122 participants having schizophrenia or schizoaffective disorder and 122 of the participants having other diagnoses): 1) TSW, or 2) CSW. The TSW and CSW programs will be delivered by the same Cognitive Specialists, who will work as members of the SE team to integrate cognitive and vocational services. All participants will continue to receive SE services. Participants will be assessed at baseline, post-treatment at 8 months (after completion of the active teaching components of TSW or CSW), and at 16 and 24 months post-baseline to evaluate cognitive functioning, symptoms, and quality of life. All work outcomes will be tracked weekly.


Condition Intervention
Schizophrenia
Schizoaffective Disorder
Chronic Mental Disorder
Major Depression
Bipolar Disorder
Behavioral: The Thinking Skills for Work Program
Behavioral: The Cognitive Skills for Work Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Dismantling Study of Cognitive Remediation for Supported Employment

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • AMOUNT OF EMPLOYMENT [ Time Frame: 24 MONTHS ] [ Designated as safety issue: No ]
    TOTAL HOURS OF EMPLOYMENT FROM BASELINE TO 24 MONTHS. TOTAL WEEKS OF EMPLOYMENT FROM BASELINE TO 24 MONTHS. TOTAL NUMBER OF JOBS HELD FROM BASELINE TO 24 MONTHS.


Secondary Outcome Measures:
  • EXECUTIVE FUNCTIONING AND MEMORY [ Time Frame: BASELINE, 8, 16, and 24 months. ] [ Designated as safety issue: No ]

    CHANGE FROM BASELINE IN EXECUTIVE FUNCTIONING AND MEMORY AT 8 MONTHS USING THE MATRICS COGNITIVE ASSESSMENT BATTERY.

    CHANGE FROM BASELINE IN EXECUTIVE FUNCTIONING AND MEMORY AT 16 MONTHS USING THE MATRICS COGNITIVE ASSESSMENT BATTERY..

    CHANGE FROM BASELINE IN EXECUTIVE FUNCTIONING AND MEMORY AT 24 MONTHS USING THE MATRICS COGNITIVE ASSESSMENT BATTERY..



Estimated Enrollment: 244
Study Start Date: September 2012
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: The Thinking Skills for Work Program
The Thinking Skills for Work Program includes 5 components delivered by a Cognitive Specialist who works collaboratively with the consumer's Employment Specialist: a) assessing the consumer's strengths and weaknesses in cognitive functioning, and analysis of the contribution of cognitive impairments and other factors to job losses and difficulties obtaining a job; b) teaching coping strategies for dealing with cognitive challenges associated with job search or maintaining a job; c) computer cognitive training involving cognitive exercises with a commercially available software program, which is designed to improve the broad range of cognitive skills through a combination of practice and strategy coaching by the Cognitive Specialist; d) job search planning; and e) job support consultation.
Behavioral: The Thinking Skills for Work Program
The Thinking Skills for Work includes assessment of cognitive strengths and weaknesses and their relationship with work history, computerized cognitive practice, compensatory strategy training, and integration of cognitive and work services.
Active Comparator: The Cognitive Skills for Work Program
The Cognitive Skills for Work Program includes 4 components delivered by a Cognitive Specialist who works with the consumer's Employment Specialist: a) assessing the consumer's cognitive strengths and weaknesses their relation to job history b) teaching coping strategies for cognitive challenges associated with job search or maintenance c)job search planning, in which the consumer and the Cognitive and Employment Specialists help identify job leads based on the consumer's interests, and identify cognitive coping strategies and supports the consumer may need to succeed at the workplace; and d) job support consultation, in which the Cognitive and Employment Specialists consult with the consumer on additional cognitive coping strategies to enable the consumer to meet the demands of the job.
Behavioral: The Cognitive Skills for Work Program
The Cognitive Skills for Work includes assessment of cognitive strengths and weaknesses and their relationship with work history, compensatory strategy training, and integration of cognitive and work services.

  Hide Detailed Description

Detailed Description:

Unemployment is a major burden for people with severe mental illness (SMI) such as schizophrenia, with competitive work rates typically between 10-20%. Over the past two decades, supported employment (SE) has been shown to improve competitive work in persons with SMI, and it is now considered an evidence-based practice (EBP). However, there is a need to improve the effectiveness of SE, as 30-60% of consumers work little or not at all, and jobs are often brief and end unsuccessfully. Cognitive remediation, when combined with vocational rehabilitation, has shown promise for improving work outcomes, including in consumers in SE. The most extensively studied approach is the Thinking Skills for Work (TSW) program, developed by this research group, which incorporates computer-based cognitive exercises to restore cognitive skills and teaching compensatory strategies by a Cognitive Specialist who is integrated into the vocational rehabilitation team. Five randomized controlled trials (RCTs), two conducted in SE programs (including one previously conducted by this research group), have shown that adding the TSW program to vocational (SE) services improves work and cognitive outcomes compared to vocational (SE) services alone.

The proposed study takes the next bold step of "dismantling" the TSW program to evaluate whether the cognitive practice exercises component is critical to improving outcomes in SE, or whether a more streamlined and efficient version of the program that focuses only on teaching compensatory skills is sufficient. The study will also yield important information about whether some consumers benefit from computer cognitive exercises, but not others, permitting the TSW program to be individually tailored to consumers' personal needs.

In preparation for the proposed study we developed, standardized, and pilot tested a variant of the TSW program, the Cognitive Skills for Work (CSW) program, that teaches compensatory skills for managing cognitive difficulties but omits computer cognitive exercises, resulting in a program that is approximately one-half the intensity of the original TSW program. A small ongoing pilot study indicated that consumers in SE could be readily engaged and retained in the CSW program and obtain work, supporting the feasibility of this streamlined version of TSW. The proposed research will be an RCT conducted at two high fidelity SE programs, comparing the effects of the TSW and CSW programs in consumers enrolled in SE.

The following hypotheses will be tested:

  1. Primary Hypothesis: Participants in TSW will have better competitive work outcomes than those in the CSW program. This hypothesis is based on the fact that virtually all cognitive remediation research on SMI has included cognitive exercises designed to restore cognitive skills, such as the computer-based cognitive exercises in TSW, with some programs also teaching compensatory strategies. If the null hypothesis is not rejected, and TSW is found to be not significantly more effective than CSW, then dissemination efforts can focus on the more efficient CSW.
  2. Secondary Hypothesis: Participants in TSW will improve more in cognitive functioning than those in CSW. This hypothesis is based on the same rationale as Hypothesis #1.

Exploratory Analyses In addition to evaluating whether the TSW and CSW programs differ overall in their impact on vocational and cognitive outcomes, we will explore whether consumer characteristics can be identified that predict a differential response to either program. For example, it is possible that consumers with more severe cognitive impairment will respond better to the full TSW program, whereas those with less severe impairment may benefit equally well from the more efficient CSW program.

The proposed research has high potential impact for improving the outcomes of SE, an established EBP for increasing competitive work in SMI, but whose effectiveness is limited by the extent of consumers' cognitive impairment. Maximizing the efficiency of the TSW program, a cognitive remediation program shown to improve work outcomes in two RCTs of SE programs, by determining whether a more streamlined version of the program that requires about one-half the time to implement (the CSW program) is equally effective, could reduce the costs of disseminating and implementing the program, making it accessible to more consumers. This study could also help identify which consumers benefit most from the cognitive exercises component of TSW, thereby facilitating tailoring of the program to the individual's personal needs. Ultimately, this research could play a critical role in making the dream of competitive work a reality for many consumers with SMI.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic mental disorder
  • Minimum age 18.
  • Unemployed
  • Wants employment
  • Must be a recipient of services at one of two participating agencies
  • Fluent in English.
  • Cognitively impaired, as defined by 1.0 SD below normative scores in memory or executive functioning
  • Willing and legally able to provide informed consent to participate in study. Subjects with court appointed legal guardians will be included.

Exclusion Criteria:

-History of neurological conditions that impair cognition

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01683539

Locations
United States, Illinois
Thresholds Recruiting
Chicago, Illinois, United States, 60613
Contact: Nicole Pashka, M.S.    773-572-5265    Nicole.Pashka@thresholds.org   
United States, New Hampshire
The Mental Health Center of Greater Manchester Recruiting
Manchester, New Hampshire, United States, 03103
Contact: Susan Guarino, RNC    603-668-4111    guarinos@mhcgm.org   
Sponsors and Collaborators
Boston University
Investigators
Principal Investigator: Susan McGurk, Ph.D. Center for Psychiatric Rehabilitation, Boston University
  More Information

No publications provided

Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT01683539     History of Changes
Other Study ID Numbers: 2837E, 2R01MH077210-05A1
Study First Received: August 17, 2012
Last Updated: July 29, 2014
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Keywords provided by Boston University:
Schizophrenia
Chronic Mental Disorder
Employment
Cognitive remediation
Vocational rehabilitation

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder, Major
Disease
Mental Disorders
Psychotic Disorders
Schizophrenia
Affective Disorders, Psychotic
Behavioral Symptoms
Depressive Disorder
Mood Disorders
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 19, 2014